Product Safety Engineer - Medical Device

Employment Status
Regular

Time Type
Full time

CSA Group is a standards development and product certification organization with a vision of making the world a better, safer, more sustainable place. Headquartered in Canada, CSA Group operates globally with more than 30 labs and offices across Europe, Asia and North America. The organization tests, inspects and certifies a wide range of products to meet safety, performance and environmental impact requirements.

Our employees take pride in making a difference in peoples lives through the work we do, and we are looking for people like you to help make it happen.

Canadian Standards Association (CSA Group), a standards development and product certification organization, seeks an experienced Product Safety Engineer, Medical Devices in its Irvine, CA office to position CSA Group as the leading and pre-eminent choice for certification across all sectors. Based throughout North America and reporting directly to the Product Group Managers (PGMs), this is a dynamic opportunity with growth potential for a keener, systematic and process-oriented individual who can see the big picture and pay attention to detail.

CSA Group offers competitive advantages to global medical device manufacturers. The use of medical equipment spans professional healthcare facilities, hospitals, clinics and home environments. As medical equipment technology evolves, so do the development of medical safety standards used to verify Basic Safety and Essential Performance. Risk Management is a crucial element in the design concept of medical equipment and the safety certification process.

The Product Safety Engineer will be responsible for the safety certification of new and leading-edge products, systems and technologies based on CSA Group and other recognized Standards Development Organizations.

• Independently manage certification projects concurrently, ensuring compliance with all applicable safety requirements, achieving completion within time frames and cost deadlines. Evaluate products against the requirements of national/international standards and precedent decisions.
• Demonstrate technical competency to review the work of others.
• Demonstrate technical competency in their certification programs.
• Able to accurately perform evaluation and review of complex, unique or unusual product types.
• Demonstrates the ability to consistently manage multiple projects concurrently while maintaining on-time and on-budget performance.
• Able to maintain high productivity in line with company expectations.
• Reviews test data, reports and authorizes application of Certification Marks. Prepares and/or signs Certification Reports and Certificates of Compliance.
• Conduct construction evaluation, ensuring the unit complies with the construction section of the standard; identifies rationale for compliance or non-compliance.
• Collaborate with Lab Technician to create a work order which tests are required and the order of the tests and the number of samples required.

• Bachelor's Degree in Engineering with likely 6 or more years of job-related experience; or Degree/Diploma in Engineering Technology or related technical field with 8 or more years’ experience.

• Thorough knowledge of Standards and testing procedures.
• Knowledge of CSA, UL and IEC Standards - 61010 and 60601.
• Thorough knowledge of CSA certification options, programs and services applicable to a variety of equipment.

• High level of interpersonal and communication skills; customer service skills.
• Possess strong organizational, time and project management skills to complete tasks independently and efficiently.
• Ability to work unsupervised, in a team-based environment.
• Read, interpret and develop engineering drawings.
• Computer proficiency (Microsoft Office).
• Use of various lab equipment, instruments and tools.
• Work well under a tight schedule in a team environment.
• See the big picture and the smaller pieces that contribute to success.
• Be detail oriented with the ability to deliver complex projects on time and bring breakthrough thinking and new processes to difficult situations.
• Build on innate knowledge by taking the…